38898 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the General Atomics Facility in La 

Jolla, California, To Be Included in the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: NIOSH gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees from the 

General Atomics facility in La Jolla, 

California, to be included in the Special 

Exposure Cohort under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: General Atomics. 

Location: La Jolla, California. 

Job Titles and/or Job Duties: All 

Atomic Weapons Employees who 

worked for General Atomics at its 

facility in La Jolla, California, during the 

period from January 1, 1960 through 

December 31, 1969, for a number of 

work days aggregating at least 250 work 

days, occurring either solely under this 

employment or in combination with 

work days within the parameters 

established for one or more other classes 

of employees included in the Special 

Exposure Cohort. 

Period of Employment: January 1, 

1960 through December 31, 1969. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2014–15988 Filed 7–8–14; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Improving Hospital Informed Consent 

With an Informed Consent Toolkit.’’ In 

accordance with the Paperwork 

Reduction Act, AHRQ invites the public 

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by September 8, 2014. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Improving Hospital Informed Consent 

With an Informed Consent Toolkit 

The ultimate aim of this project is to 

pilot test a toolkit to improve the 

informed consent process in U.S. 

hospitals. Clinical informed consent is 

the process by which a patient is told 

about the risks and benefits of proposed 

treatments or procedures, as well as 

alternatives, and makes a decision based 

on that information. Informed consent 

may be jeopardized by incorrect 

clinician assumptions about patient 

comprehension, the manner in which 

consent is sought, and poor readability 

of consent forms (Paasche-Orlow et al., 

2013). All too frequently, patients do 

not understand the risks, benefits, and 

alternatives of their treatments even 

after signing a consent form (Braddock 

et al., 1999; Sudore et al., 2006). Deidentified accreditation data analyzed as 

part of AHRQ’s preliminary research for 

this data collection effort suggest that 

some hospitals are not following the 

basic ethical principles underlying 

informed consent. These data, as well as 

the guidance from the study’s Expert 

and Stakeholder Panel, indicate that 

hospital administrators and clinicians 

could benefit from training on evidencebased practices to improve the informed 

consent process. These include 

improving communication, using 

interpreters to meet the communication 

needs of patients with limited English 

proficiency, using high-quality decision 

aids to support the informed consent 

discussion, and using teach-back to 

verify patient understanding (Temple 

University Health System, 2009). 

Hospital system changes that can 

facilitate these practices include 

improving hospitals’ informed consent 

policies and enhancing the 

infrastructure that supports the 

informed consent process (e.g., 

interpreter services, high-quality 

decision aids, easy-to-understand 

forms). 

Building upon a previously published 

guide, a review of the literature, and the 

aforementioned analysis of de-identified 

accreditation data, AHRQ has developed 

a new Informed Consent Toolkit. 

Toolkit content will be delivered via 

two training modules of approximately 

one hour each (one for hospital leaders, 

the other for frontline clinical staff), to 

be offered through a Learning 

Management System. Clinical staff 

taking the training will be eligible for 

continuing education (CE) credit. 

AHRQ will pilot test the toolkit to 

assess: 

• Facilitators of and barriers to 

implementing the toolkit 

• Effectiveness of the toolkit in 

improving informed consent processes 

and relevant outputs and outcomes 

Pilot test results will be used to 

improve the toolkit and provide 

information to hospitals considering 

using it to improve their informed 

consent processes. The pilot test will 

take place in four hospitals. Each 

participating hospital will be asked to: 

• Train the leaders of their choosing 

using the training module Champion 

improvements in their informed consent 

policies and processes based on the 

information and tools in the leader 

training. 

• Train frontline staff members in 

four units, including at least one 

surgical unit. Using the frontline 

training module. 

• Implement improvement initiatives 

over a period of two to six months in 

participating units based on materials 

presented in the frontline training. 

Æ In at least one unit implementation 

will last at least three months and use 


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